Christopher C. DeMerlis

The authors, representing the International Pharmaceutical Excipients Council, propose a new evaluation procedure, including tiered toxicology testing for excipients.

Natural gums and mucilage are biocompatible, cheap, readily available, and represent a potential source of excipients. The authors examine the functionality of mucilage extracted from the leaves of Hibiscus rosa-sinensis Linn as an excipient in a sustained-release tablet formulation.

The authors propose several models for independent evaluation of new excipients.

A global drug master file system may pave the way for faster qualifications of new excipients and the industry's acceptance of their use in drug therapies.